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Patent Searching and Data


Title:
A METHOD FOR INSERTING IN CAPSULES AND PROTECTING SUBSTANCES TO BE MIXED IN A SOLVENT BEFORE USE
Document Type and Number:
WIPO Patent Application WO/2012/153216
Kind Code:
A1
Abstract:
The invention relates to a method for inserting in capsules and protecting substances to be mixed in a solvent before use. The method uses known capsules provided with a reservoir and a cutter element and envisages a step of introducing an active substance, such as freeze-dried lactobacilli, in powder form into the capsule, a further step of introducing internally of the capsule, in contact with the active substance, a quantity of an oil, with a water percentage of less than 1 %, in a proportion by weight which is variable about 4 times the weight of the powder of the active substance; the capsule thus filled undergoes a light shaking step such as to form, internally thereof, a suspension of the particles of the powder in the oil.

Inventors:
BENEDETTI VANNI (IT)
Application Number:
PCT/IB2012/052025
Publication Date:
November 15, 2012
Filing Date:
April 23, 2012
Export Citation:
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Assignee:
BIODUE S P A (IT)
BENEDETTI VANNI (IT)
International Classes:
B65B29/10; B65D51/28
Domestic Patent References:
WO2007085710A12007-08-02
WO1993024024A11993-12-09
Foreign References:
US20100089790A12010-04-15
EP0322996A21989-07-05
Other References:
None
Attorney, Agent or Firm:
CASADEI, Giovanni (Via Vellani Marchi 20, Modena, IT)
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Claims:
Claims.

1) . A method for inserting in capsules and protecting substances to be mixed in a solvent before use, of a type which uses capsules provided with a reservoir, superiorly open and provided with a rupturable bottom, and a tubular cutter element which is closed at one end and provided with a cutter at the opposite end thereof which is open, and of a type in which there is present a step of introducing an active substance, such as freeze-dried lactobacilli or the like, in powder form into the capsule, characterised in that it comprises a further step of introducing internally of the capsule, in contact with the active substance, a quantity of an oil with a proportion by weight which is variable from 2 to 8 times the weight of the powder of the active substance.

2) . The method according to claim 1, characterised in that the oil used has a water percentage of less than 1%.

3) . The method according to claim 1 , characterised in that it uses an edible oil such as sunflower oil.

4) . The method according to claim 1, characterised in that the oil is used with a proportion by weight of 4 times the weight of the powder of the active substance.

5) . The method according to claim 1, characterised in that the powder of the active substance and the oil are introduced, one after another, into the cutter.

6) . The method according to claim 1, characterised in that after the filling and closure of the capsule a step of lightly shaking the packed capsule is performed such as to form, internally thereof, a suspension of the powder particles in the oil.

Description:
A method for inserting in capsules and protecting substances to be mixed in a solvent before use.

Description

The present invention relates to a method for inserting in capsules and protecting substances to be mixed in a solvent before use. In particular, the invention relates to inserting in single-dose capsules and protecting lactobacilli, even though the method can be used for substances having problems analogous to those of lactobacilli, with particular reference to their sensitivity to humidity.

Another example of substances that can be introduced in capsules using the method according to the invention is represented by vitamins, be they single vitamins or vitamin complexes, which can present risks of oxidation or have a critical behaviour in the presence of humidity.

For packaging substances to be mixed at the moment of use, in particular for inserting an active substance within a solvent so as to obtain a solution immediately prior to use of the solution itself, there have long been known packages, in particular of a single-dose type, which comprise a container containing the solvent (generally a liquid), on which there is mounted a capsule, of varying kinds, normally made of plastic material. There are known capsules which are provided with a reservoir in turn provided with a rupturable bottom; sliding inside the reservoir there is a cutter that possesses a cutter element which, following a pressure exerted thereupon, provokes the rupture of the rupturable bottom. In the reservoir, and in particular in the internal cavity of the cutter, there is contained an active substance, which, upon the rupture of the rupturable bottom of the external part of the reservoir, falls inside the container and is dissolved in the liquid contained in the container.

Normally, the capsule containing the active substance is first prepared and subsequently fitted onto the container. The active substance is inserted internally of the capsule, which is subsequently closed, and possibly associated with a closure capsule, and is thus ready to be used in combination with the container containing the solvent.

Given that the substances inserted in these types of capsules are particularly sensitive to humidity, systems for protecting the substances themselves from humidity have long been studied, since humidity leads to a rapid degradation of the substances. This problem is particularly felt in the case of lactobacilli which are inserted in the capsules in freeze-dried form and which, in contact with humidity, are revitalized and die in a rather short time; depending on the mode and time of storage of the freeze-dried lactobacilli inside the capsule, at the time of use a mortality of lactobacilli as high as 70-80% can be observed. Naturally, if the storage mode and time are other than those imposed by the manufacturer, a complete mortality of the lactobacilli present in the capsules may be reached, so that the use thereof is not possible.

In the case of lactobacilli, and also other substances, quantities far exceeding the actual ones needed for use are normally introduced in the capsules in order to have, at the time of use, a sufficient quantity of active substance.

There have also been devised mechanical barriers realised with multilayer sheets containing aluminium, and particular configurations of the capsules and of the reservoirs that contain the substance serving to provide barriers which impede, or limit, the passage of humidity toward the inside of the capsule and thus toward the substance. These known methods and capsules, besides providing results that are not always appreciable, are particularly costly due both to an excessive use of active substances and a higher cost of the capsules provided with such barriers.

The object of the present invention is to obviate these drawbacks by providing a method for inserting in a capsule active substances and protecting such substances from humidity which enables the disadvantages of the prior art to be eliminated.

One advantage of the present invention is that of providing a method that can be implemented with the capsules presently in use.

Further characteristics and advantages of the present invention will be better apparent from the detailed description that follows of the steps of the method herein.

The method herein is used to fill capsules with substances, in particular lactobacilli in freeze-dried form, vitamins or vitamin complexes, which must be mixed, prior to use, in a solvent contained in a container such as, for example, a bottle or a vial; the method uses a capsule, in which there is inserted an active substance, and which, like the known capsules of this type, is provided with a reservoir that is superiorly open and provided with a rupturable bottom; coupled inside the reservoir there is a tubular cutter element which is closed at one end and provided with a cutter at the opposite end, which is open. The above-described capsules of this type have long been known and can be used to implement the method herein. The method of the invention comprises initially a step of introducing an active substance in powder form, in particular freeze-dried lactobacilli, vitamins or vitamin complexes, into the capsule; for reasons that will be better apparent below, this step takes place with the cutter positioned with the open part thereof turned upward; it is noted that the upward and downward positions are in relation to the ground, assumed as "downward". Subsequently one proceeds with a further step of introducing internally of the capsule an oil which, inside the capsule, comes into contact with the active substance; the above-described position of the cutter enables the oil, which is liquid, to be easily introduced from above by means of a simple filler that is associated with normal machines for filling capsules of this type.

The oil used is an oil which has a water percentage of less than 1%; for this purpose it has been verified, with particular reference to lactobacilli, that an edible oil such as sunflower oil can be conveniently used, although, depending on the characteristics of the active substance, edible oils having analogous characteristics or oils of a different nature can be used.

The proportions by weight between the oil and active substance are variable, with a weight of the oil which is from 2 to 8 times the weight of the powder of the active substance. Good results have been obtained with a proportion by weight of the oil which is 4 times the weight of the powder of the active substance.

Once the active substance and the oil have been introduced into the cutter, a step of fitting the reservoir onto the cutter is performed in order to close the capsule.

The sequence of introduction of the substances into the capsule, which, as said, is carried out by inserting, in order, the active substance powder and the oil in the cutter, allows the oil, when the capsule is closed and subsequently moved, to "wet" (or rather lubricate) the surfaces of contact between cutter and reservoir, thus providing a more secure barrier to humidity, which could migrate into the capsule through the contact area of such surfaces; the presence of oil also facilitates the sliding that takes place between the cutter and the reservoir at the time of use.

The method herein envisages that, after the filling and closure of the capsule, a step of lightly shaking the capsule is performed. This step can be performed, for example, by using a vibrating system applied to the conveyor which conveys the packed capsule to the packaging line, or by means of a conveyor having a tortuous path that obliges the capsule to roll during conveyance. This step has the purpose of forming inside the capsule not an emulsion (which would damage the product) but rather a suspension of the particles of the active substance in the oil; for this reason, only light movements of the capsule are necessary, easily obtainable with the above- described systems.

In this manner, the oil will coat the individual particles of active substance and create a protection against any humidity that may penetrate inside the capsule, even if all of the systems of a known type, which try to prevent this event, do not fully achieve their purpose (as often occurs).

In the capsule, therefore, a sort of paste forms which, at the time of use, is dispersed with ease in the solvent when it comes into contact with the latter.

Through experimental trials performed on capsules containing freeze-dried lactobacilli, it was verified that the mortality of the lactobacilli packed according to the method of the invention is, storage conditions and times obviously being equal, distinctly lower than the mortality of the lactobacilli packed according to traditional methods; to give an example, in some tests performed maintaining two packages obtained with the same capsules, one using traditional methods and one using the method herein, under the same storage conditions for an equal amount of time, the mortality went from 70- 80% (traditional method) to around 20% (method herein). The method herein thus makes it possible, using capsules and machines of a known type, to obtain effective humidity protection for the active substance contained in the capsule.